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Study on the Effects of Sparsentan and Irbesartan for Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Sparsentan on a kidney disease known as Focal Segmental Glomerulosclerosis (FSGS). FSGS is a condition that affects the kidney's filtering units, leading to scarring and potential kidney damage. The study aims to evaluate how well Sparsentan can protect the kidneys over a long period and to assess its safety for patients with this disease.

Participants in the study will receive either Sparsentan or another medication called Irbesartan, which is commonly used to treat high blood pressure and kidney problems. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving which medication during the trial. This helps ensure that the results are unbiased. The trial will also include an "open-label" phase, where all participants will receive Sparsentan to further assess its long-term effects.

The study will take place over several years, with regular check-ups to monitor kidney function and overall health. Participants will take the medication in tablet form by mouth. The goal is to determine if Sparsentan can effectively reduce the progression of kidney damage in FSGS patients compared to Irbesartan, while also ensuring that it is safe and well-tolerated.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Double-blind period

    During this phase, the patient will receive either sparsentan or irbesartan in tablet form. Both medications are taken orally.

    The purpose of this phase is to compare the effects of sparsentan with irbesartan on kidney function in patients with primary focal segmental glomerulosclerosis (FSGS).

    The patient will be monitored for changes in kidney function and protein levels in the urine over approximately two years.

  2. Step 2

    Medication administration

    The patient will take the assigned medication daily. The dosage and specific instructions will be provided by the study team.

    Regular check-ups will be scheduled to monitor the patient's health and response to the medication.

  3. Step 3

    Safety and efficacy assessments

    Throughout the double-blind period, the patient's kidney function will be assessed by measuring the estimated glomerular filtration rate (eGFR) and protein levels in the urine.

    Safety assessments will include monitoring for any side effects or adverse reactions to the medication.

  4. Step 4

    Open-label extension period

    After completing the double-blind period, the patient may enter the open-label extension phase if they meet specific criteria.

    In this phase, all patients will receive sparsentan to further evaluate its long-term effects on kidney function and overall health.

  5. Step 5

    Ongoing monitoring

    During the open-label extension, the patient's kidney function, protein levels in the urine, and overall health will continue to be monitored.

    Additional assessments will include changes in quality of life, body weight, vital signs, and laboratory parameters.

Who can join the trial?

9 criteria

  • The patient or their parent/legal guardian must be willing and able to provide signed informed consent or assent, which means they agree to participate in the study after understanding what it involves.
  • The patient must have a confirmed diagnosis of Focal Segmental Glomerulosclerosis (FSGS), which is a kidney condition. This can be proven by a past biopsy or genetic test showing a mutation in a specific kidney cell protein.
  • The patient must be between 18 and 75 years old and weigh at least 20 kg (about 44 pounds) at the time of screening. Patients under 18 may be included only in the United States and United Kingdom.
  • The patient must have a urine protein to creatinine ratio (UP/C) of at least 1.5 g/g (170 mg/mmol) at screening. This is a measure of protein in the urine, which helps assess kidney function.
  • The patient must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m² at screening. This is a test to check how well the kidneys are working.
  • The patient's average seated blood pressure must be between 100/60 mmHg and 160/100 mmHg. This is a measure of the force of blood against the walls of the arteries.
  • Women of childbearing potential (WOCBP) must agree to use contraception and undergo pregnancy testing as described in the study protocol.
  • For the open-label extension period, the patient must have completed participation in the double-blind period, including the Week 112 visit.
  • For the open-label extension period, the patient or their parent/legal guardian must be willing and able to provide signed informed consent for participation.

Who cannot join the trial?

10 criteria

  • Patients who do not have a diagnosis of Focal Segmental Glomerulosclerosis (FSGS) cannot participate. FSGS is a condition that affects the kidneys.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of drug or alcohol abuse cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have allergies to the study medication cannot participate.
  • Patients who have a history of non-compliance with medical treatments cannot participate.
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Investigated drugs

Sparsentan is a medication being studied for its potential to protect the kidneys in patients with a condition called primary Focal Segmental Glomerulosclerosis (FSGS). It works by blocking two types of receptors in the body: endothelin receptors and angiotensin receptors. This dual action is thought to help reduce kidney damage and improve kidney function over time. The study aims to evaluate how effective sparsentan is in providing long-term kidney protection and to monitor its safety and tolerability in patients with FSGS.

What is already known about the treatment

Sparsentan – Sparsentan is administered orally and is currently being studied in clinical trials for its potential benefits in treating focal segmental glomerulosclerosis (FSGS), a kidney disorder. It is a dual endothelin receptor and angiotensin receptor blocker, which means it works by blocking specific proteins that can cause blood vessels to constrict and increase blood pressure, thereby helping to protect the kidneys. Sparsentan is classified as an antihypertensive agent due to its ability to lower blood pressure and improve kidney function. The medication is still under investigation to confirm its long-term safety and effectiveness in patients with FSGS.

Investigated diseases

Focal Segmental Glomerulosclerosis (FSGS) – FSGS is a kidney disorder characterized by scarring in the glomeruli, which are tiny structures within the kidneys that filter waste from the blood. This scarring can lead to a loss of kidney function over time. The disease can be primary, with no known cause, or secondary, resulting from another condition. Symptoms often include proteinuria, where excess protein is found in the urine, and swelling in parts of the body due to fluid retention. As the disease progresses, it can lead to chronic kidney disease. FSGS is considered a rare disease and can affect both children and adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505494-32-00Protocol code021FSGS16010Estimated enrolment371 patientsSponsorTravere Therapeutics Inc.

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